At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,146 enrolled
Drug / intervention
Edoxaban (DU-176b) +4 moredrug
Likely dose
Edoxaban (DU-176b) 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation
In Brief
A Phase 2 clinical trial evaluating Edoxaban (DU-176b) and warfarin for Atrial Fibrillation and Thromboembolism. Completed, enrolled 1,146 participants across 91 sites in 12 countries.
Detailed Summary
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Thromboembolism
CountriesBelarus, Belgium, Bosnia and Herzegovina, Canada, Chile, Latvia, Mexico, Moldova, Russia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJul 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedJul 20, 2007
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.9 years ago
Interventions
Edoxaban (DU-176b)drug
30mg tablet once daily
Edoxaban (DU-176b)drug
60mg tablet once daily
Edoxaban (DU-176b)drug
30mg tablet two times a day
Edoxaban (DU-176b)drug
60mg tablet two times a day
warfarindrug
warfarin tablets